The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for M55 K Karaya Gum Disp. Microtape Ecg Electrode, 55.
| Device ID | K884983 |
| 510k Number | K884983 |
| Device Name: | M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 |
| Classification | Electrode, Electrocardiograph |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-29 |
| Decision Date | 1989-03-09 |